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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00180960 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia
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Scientific title:
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Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan |
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Date of first enrolment:
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June 2003 |
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Target sample size:
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100 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00180960 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Dominique Elias, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gustave Roussy, Cancer Campus, Grand Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Peritoneal seedings coming from colon, rectum, pseudomyxoma (appendix), peritoneum
(mesothelioma and serous tumors), or endocrine tumors.
- No extra-abdominal metastases
- Good general status (American Society of Anesthesiologists Physical Status score
[ASA] 1 or 2)
- Signed consent
Exclusion Criteria:
- Tumor seedings coming from other origins
- Huge peritoneal carcinomatosis (peritoneal score > 25, except for pseudomyxomas)
- Peritoneal carcinomatosis progressing rapidly
- Presence of extra-abdominal metastases
- Patients presenting contraindications to the use of oxaliplatin or irinotecan
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Appendix Tumors
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Endocrine Tumors
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Colon Tumors
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Rectum Tumors
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Peritoneum Tumors
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Intervention(s)
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Drug: Oxaliplatin and irinotecan
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Primary Outcome(s)
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To study overall survival
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Secondary Outcome(s)
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To study mortality-morbidity
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Secondary ID(s)
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CHIP4 Phase II
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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